Optical surgical device with scraping tool

ABSTRACT

An optical surgical device includes a detachable, disposable semi-flexible sheath for insertion into a patient&#39;s body. The sheath is provided with plurality of channels. One of the channels receives an endoscope for optical examination of an operative site within the patient. The remaining channels may be used for suction, drainage or irrigation of the operative site. The distal end of the sheath defines a hook-like scraping tool for removing tissue from the patient in the field of view of the endoscope.

This is a continuation of application Ser. No. 08/108,980 filed on Aug.18, 1993, now abandoned.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to optical medical devices for use insurgical procedures. In particular embodiments, the optical surgicaldevice may be used to remove tissue, blood, or other liquid andparticulate matter.

2. Description of Related Art

Certain gynecological procedures require a physician to examine,diagnose and often remove or extract tissue, blood, or other matter froman operative site within the patient. For example, in a one relativelycommon procedure, the physician must accurately locate uterine tissue tobe removed, scraped, and/or aspirated. In other procedures, thephysician may want to examine the patient's fallopian tubes or otherinternal areas to diagnose or biopsy other medical problems ordifficulties, or simply to insure that the desired results have beenachieved.

Different forms of endoscopes have been used to access and examine suchoperative sites within the patient's body. Typically, such endoscopescomprise bundles of long optic fibers which extend into the body cavitybeing examined. Some conventional endoscopes include multiple channels,or lumens, extending alongside or concentric with the optic fiberbundles. These channels may be used to introduce a flushing fluid intothe operative site or to provide a conduit for other instruments toreach the desired area.

Conventional endoscopes, however, generally do not allow a continuousflow of irrigation fluid into the operative site to clean both theoperative site as well as the endoscope, while simultaneously removingthe fluid and other particulate matter from the area. Instead, in someconventional devices, a single lumen is designated for both suction andirrigation functions. As a result, suction and irrigation cannot occursimultaneously. The suction and irrigation functions must operate in analternating fashion. In other devices in which separate channels areprovided for inlet and outlet fluids, the corresponding openingstypically operate so that a stream of fluid which is inlet through oneport is later outlet through another port in an alternating fashion.Such an endoscopic device, however, still does not operate as acontinuous flow system in which irrigation and suction can occursimultaneously and continuously.

Another drawback of some conventional endoscopic tools is that they areoften uncomfortably large or wide in diameter. For example, manytraditional endoscopes use glass rods and lenses to deliver light anddisplay images. However, due to the materials and methods used, suchrelatively large devices have been known to cause significant discomfortduring insertion and manipulation after being inserted. Often, due tothe physical size limitations of the endoscope device, the physician mayperform the surgery without visually examining the operative area.

One device which includes some of the drawbacks described above is shownin FIGS. 1-3 of U.S. Pat. No. 4,998,527 to Meyer (issued Mar. 12, 1991).Meyer discloses a complicated network of tubes combined in a metalsleeve. Each tube is designated for a specific function. For example,one of the tubes carries a resecting mechanism which breaks down largepieces of tissue into smaller pieces to be suctioned into another tube.As a consequence, however, the metal outer sleeve must be sufficientlylarge to retain the network of tubes, channels, etc.

Furthermore, conventional endoscopes are typically designed with rigidouter sleeves or sheaths made of a rigid plastic or metal material, suchas that described above in the Meyer device. Such construction, however,is often difficult to manipulate within a patient's body, and generallyrequires extensive cleaning and sterilization after each use. Althoughsome endoscopes incorporate both rigid and flexible materials forgreater maneuverability during insertion and examination, suchconstruction often requires substantial cleaning and sterilization toremove all contaminants trapped within the various crevices and openingsof the different materials.

Moreover, it is particularly problematic to properly clean and sterilizetubes and conduits which form the lumens contained within conventionalendoscopes. Because of the universal desire to maximize the patient'scomfort during the examination, the lumens are typically designed to beas small as possible. However, such small openings tend to exacerbatethe difficulty in properly cleaning and sterilizing the endoscope.

SUMMARY OF THE DISCLOSURE

Accordingly, it is an object of the present invention to provide animproved optical endoscopic device and method of making and using thesame, obviating for practical purposes the above-mentioned limitations.

These and other objects and advantages are accomplished, according to anembodiment of the present invention, by an optical surgical devicehaving an outer sheath constructed with multiple channels, or lumens,extending through the length of the sheath. The sheath, according to theillustrated embodiments, is disposable. Preferably, for each procedure,a new, presterilized sheath is used. This minimizes the risk ofcontamination and decreases the amount of time directed to the propercleaning and sterilization of the sheath and multiple channel structure.Thus, the disposable feature significantly reduces the possibility ofcontamination and infection due to inadequate cleaning or sterilizationof the sheath.

The sheath is preferably made of a semi-flexible plastic, vinyl or othermaterial appropriate for the particular application. For example, thesheath may be formed of a rigid plastic with a curved end for use as acurette in, aspiration biopsies, or other procedure in which tissue orfluid is removed around the operative site. In addition, a flat-endedsheath may be used for other examination procedures such as forfallopian tube blockage or bowel endoscopy, for example.

In the illustrated embodiment of the sheath, three channels are showndisposed adjacent each other. An endoscope is provided in one of thechannels of the sheath to enable the physician to optically examine theoperative site within the patient. The endoscope is comprised of bundlesof optic fibers which extend through the entire length of thecorresponding channels in the sheath. The endoscope is first insertedinto one of the channel openings at the proximal end of the sheath, andthen fed through the channel until it reaches the end of the channel atthe distal tip of the sheath. The endoscope can be quickly disengagedfrom the sheath by simply sliding it out of its designated channel.

The remaining channels may be occupied by suction and/or irrigationsources, or other medical devices. Preferably, the suction channel isthe largest channel so that fluid or tissue scraped or removed from theoperative site do not clog or block the pathway. A source of irrigationis supplied to flush the operative site, if necessary, as well as toclean the viewing area at the distal tip of the endoscope. Theirrigation solution is simply supplied through the designated irrigationchannel while the patient's bodily tissue and fluid, as well as theirrigation solution, are drained through the suction channel.

Thus, the above-described arrangement of the present invention allowsthe physician to visually examine, for example, a patient's uterusbefore, during and after an intrauterine procedure. The physician mayirrigate or insufflate the operative site, accurately locate the targettissue, and then scrape and/or remove by suction the tissue. Because thedisposable sheath is quickly removable and replaceable, a variety ofdifferent procedures may be used with a single endoscope. For example,other procedures which may also be performed using the illustratedembodiments of the present invention include aspiration biopsy,artificial insemination and fallopian tube examination. In addition,further embodiments of the present invention may be used as a pediatriccystoscope, amniocentesis scope, female urethroscope or as a malecystoscope.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description will be made with reference to the accompanyingdrawings, wherein like numerals designate corresponding parts in theseveral figures.

FIG. 1 is a perspective view of an optical surgical device according toone embodiment of the present invention.

FIG. 2 is a cross-sectional view of a portion of the optical surgicaldevice along the lines 2--2 shown in FIG. 1.

FIG. 3 is a cross-sectional view of a portion of the optical surgicaldevice along the lines 3--3 shown in FIG. 1.

FIG. 4 is a side view of a portion of the optical surgical device of theembodiment in FIG. 1.

FIG. 5 is a perspective view of one aspect of the optical surgicaldevice.

FIG. 6 is a cross sectional view of a portion of the optical surgicaldevice along the lines 5--5 shown in FIG. 1.

FIG. 7 is a side view of a portion of one aspect of an optical surgicaldevice.

FIG. 8 is a side view of a portion of another aspect of an opticalsurgical device.

FIG. 9 is a perspective view of an optical surgical device according toanother embodiment of the present invention.

FIG. 10 is a cross-sectional view of a portion of the optical surgicaldevice along the lines 10--10 shown in FIG. 9.

FIG. 11 is a cross-sectional view of a portion of the optical surgicaldevice along the lines 11--11 shown in FIG. 9.

FIG. 12 is a side view of a portion of the optical surgical device ofthe embodiment shown in FIG. 9.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following detailed description is of the best presently contemplatedmode of carrying out the invention. This description is not to be takenin a limiting sense, but is made merely for the purpose of illustratingthe general principles of embodiments of the invention. The scope of theinvention is best defined by the appended claims.

FIG. 1 is a perspective view of an optical surgical device 10 accordingto an embodiment of the present invention. As discussed in more detailbelow, embodiments of the present invention are suitable for use in avariety of intrauterine or other internal examination procedures, suchas, aspiration biopsy, artificial insemination techniques,amniocentesis, chorionic villa sampling, and urethra, urinary bladderand bowel endoscopy, for example. Embodiments of the present inventionprovide significant advantages in that the physician may more clearlyexamine the body cavity or operative area during the intrauterine orinternal surgical procedure with minimal obstruction. In addition, otherembodiments of the present invention allow for video documentation ofthe procedure if desired.

Thus, the physician may accurately locate the tissue to be removed,irrigate or insufflate the operative site, and scrape and/or use suctionto remove the desired tissue, while concurrently viewing each step ofthe procedure. Consequently, the occurrence of inadvertent accidentssuch as perforation of the operative site or body cavity, e.g., thepatient's uterus, is significantly reduced.

While various embodiments of the present invention may also be suitablefor other surgical and diagnostic procedures, as described in moredetail below, the described embodiments are preferably directed for usewithin any areas of a patient's body for which visual examination isparticularly helpful. For example, during a biopsy procedure of tissueor fluid within a patient's urethra or bladder, optical diagnosis andexamination of the surgical procedure may be especially useful. It willbe recognized that further embodiments of the present invention may besuitable for various other biopsy procedures, such as (but not limitedto) biopsies of the breast, lung, kidney, and almost any other internalorgan or cavity in which optical probing capabilities are necessary toreach and ultimately examine the desired operative site.

As illustrated in FIG. 1, the optical surgical device 10 comprises,generally, an elongated sheath 12 containing multiple channels 14, 16,and 18. Each channel is designated for a specific function. For example,channel 14 may be designated for suction or drainage purposes.Preferably, the center channel 16 is designated for insertion of anendoscope (not shown). The endoscope may be inserted in the channel 16at the proximal end 24 of the sheath 12, and pushed through to thedistal end 20 of the sheath 12. The endoscope extends through the lengthof the sheath 12. The endoscope is preferably formed of a bundle ofoptical fibers which carry images from the distal end of the device tothe proximal end. In addition, light delivery fibers may be provided forilluminating the examined area. Depending upon the configuration of theendoscope, a light source may be coupled to the endoscope fibers toilluminate the operative site.

The third channel 18 is provided as an irrigation line through which anirrigating or flushing fluid may flow to irrigate the operative siteduring the surgical procedure, while simultaneously cleaning theendoscope. In other embodiments, the irrigation channel 18 may be used,for example, as a gas inflow channel through which a gas, such as carbondioxide (CO₂), may be directed to insufflate the operative site.

It will be recognized that the suction and irrigation functions may beperformed using the designated channels in the sheath 12 throughseparate tubing which may be connected to the channels provided in thesheath 12. For example, individual suction and irrigation tubes, orlines, may be attached to the external sources of the suction andirrigation. Thus, the preformed, predefined channels themselves maycomprise the pathways for suction and irrigation.

As illustrated in FIG. 1, the proximal end 24 (on the left side of thefigure) of the optical surgical device 10 is provided with two ports 22and 23. As shown in FIG. 2, the suction/irrigation port 22 includes theproximal openings for the suction and irrigation channels 14 and 18,respectively. In FIG. 3, the cross-section of the proximal endoscopeport 23 shows the endoscope channel 16 and viewing area at approximatelythe center of the port 23. Preferably, the suction/irrigation port 22 isoffset from the proximal endoscope port 23 for reasons discussed below.

As shown in FIGS. 1 and 4, an eyepiece port 32 is coupled to the openend of the proximal endoscope port 23. Preferably, the eyepiece port 32extends along the same line as the sheath 12 and endoscope channel 16.The in-line construction of the eyepiece port 32 facilitates easieraccess to the viewing angle as the sheath 12 is rotated or manipulatedwithin the operative site. Otherwise, if the eyepiece port is offsetfrom the body of the sheath and endoscope, as in some conventionalendoscopes, the physician must physically adjust his or her viewingposition to accommodate the changing position of the rotating eyepieceport. Instead, in preferred embodiments of the present invention, thephysician does not have to sacrifice balance and control of the opticaldevice while adjusting the position of the device during the examinationprocedure.

The eyepiece port 32 is attached over the endoscope port 23 at theproximal end 24 of the sheath 12. The funnel-shaped eyepiece port 32receives a conical eyepiece 33 (FIG. 5). Preferably, a metal or rigidcovering surrounds the optical fibers of the endoscope for coupling tothe distal end of the eyepiece 33. Various eyepieces 33 may be used fordifferent examination procedures. For example, depending upon thedesired degree of optical examination, the eyepiece may requiremagnifying or focusing capabilities. A preferred eyepiece embodiment, asillustrated in FIG. 5, includes a focusing ring 36 located at theproximal end of the eyepiece 33 for manual adjustment by the user. Itwill be recognized, however, that various other manual or automaticfocusing and magnifying techniques may be implemented to enable a clear,focused view of the operative site through the eyepiece and endoscopeassembly.

The distal end of the eyepiece 33 is provided with a conical-shapedlocking mechanism 38 for attachment to the eyepiece port 32, shown inFIG. 4. The locking mechanism 38 is inserted into the funnel shapedopening of the eyepiece port 32 for a secure fit. Preferably, a screw-ontype locking mechanism is used to screw the eyepiece 33 to the eyepieceport 32. However, other friction-fit devices or methods may also be usedto ensure a tight seal between the eyepiece and the sheath. In addition,a gasket 34 may be used to further prevent leakage of irrigatingsolution and other fluid, or to prevent the insufflating gas fromescaping, around the periphery of the eyepiece port connection.Alternatively, port 32 can be integrally formed on the proximal end 24of the sheath 12.

A preferred eyepiece has been developed by Ideation Engineering in whichglass lenses and prisms are used to magnify and focus images seenthrough the endoscope. A focusing ring is provided on the eyepiece. Theconical-shaped eyepiece includes a cone-shaped locking mechanism whichcan be twist-fit into the eyepiece port. The eyepiece may be connectedto a medical video camera or may be used for direct viewing.

As described above, the suction/irrigation port 22 is preferably offsetfrom the proximal endoscope port 23 to prevent obstruction of orinterference with the viewing area around the endoscope eyepiece, aswell as to separate the sources of fluid or gas from the eyepiece.Depending upon the rigidity of the material which forms the sheath 12and the ports 22 and 23, an angle support brace 26 may be provided inthe angular separation between the suction/irrigation port 22 and theproximal endoscope port 23. For example, if the sheath and therespective channels and ports are made of a flexible material, the anglesupport brace 26 may be used to keep the tubing, cables, etc. of thesuction and irrigation supply lines from draping over the endoscopeeyepiece. Thus, the support brace 26 functions to maintain and brace theseparation between the two ports to avoid obstruction of the endoscopeviewing area by the suction/irrigation supply lines.

FIG. 2 shows the suction/irrigation port 22 divided into two channelopenings 14 and 18. The diameters of the suction and irrigation channelsmay vary depending upon the desired use for the optical surgicalinstrument. For example, the cross-section of the suction (or drainage)channel 14 may be larger than that of the irrigation channel 18. Thus,if the tissue to be removed around the operative site is primarilycomprised of the endometrial lining of the uterus, it may be desirableto have a large suction channel 14 relative to the irrigation channel 18so that the tissue can be scraped and removed from the operative areawithout clogging the channel. Simultaneously, the operative site may beirrigated with a thin, continuous stream of water or other irrigatingsolution.

For other procedures such as, for example, aspiration biopsy orfallopian tube insemanation, the suction channel 14 may be smallrelative to the irrigation channel 18 to limit or control the amount oftissue and/or fluid injected into or removed from the operative site.For example, in an insemination procedure, it may be desirable to employa sheath having a large irrigation channel for use as a fluid injectionchannel. A "suction" function then may be completely unnecessary.

As shown in FIG. 2, the proximal openings of the suction and irrigationchannels 14 and 18, respectively, are circular or oval in shape. It willbe recognized that the particular configuration, shape, and size of eachof the channels within the sheath 12 may vary according to theparticular application. For example, the shapes of the suction channel14 and the irrigation channel 18 will preferably be circular ifstandard-gauge tubing is used, rather than using the channels as directconduits between the suction/irrigation port 22 and the distal tip 28 ofthe sheath. The sheath, as well as the channels contained therein, maythus have a variety of shapes and lengths for use in different surgicalprocedures.

In any internal examination procedure, however, the sheath preferablycontains a minimum number of channels necessary to perform the medicalprocedure, yet ensure patient comfort during insertion and manipulationof the surgical device. Thus, to meet the needs for patient comfort andcontrollability of the device during the surgical procedure, the sheathstructure 12 of the described embodiments is tapered, as illustrated inFIG. 1. The diameter of the sheath 12 is larger at the proximal end 24as compared to the distal end 20 of the sheath 12. Because the distalhalf 20 of the sheath 12 is inserted into the patient during theoperative procedure, the slim configuration of the distal end 20 of thesheath 12 minimizes patient discomfort during insertion and enhancesmaneuverability during the examination procedure. Similarly, the widerproximal end of the sheath 12 provides for easy handling and control ofthe sheath 12 by the physician.

In another aspect of the illustrated embodiment, the sheath material ispreferably semi-flexible to allow the physician to maneuver the sheathinto the desired location and position, yet sufficiently rigid forproper control of the endoscope during the examination. Thus, thematerials used to form the sheath 12 may vary depending upon theprocedure to be performed. Furthermore, the walls of the proximal half24 of the sheath may be constructed to be thicker, and therefore morerigid, than those of the distal end 20 of the sheath. In such aconfiguration, although the diameters of the channels within the sheath12 may be uniform through the entire length of the sheath, the externalstructure of the sheath may nevertheless be tapered to enhanceflexibility and manipulability of the sheath during an examination.

FIG. 6 shows a cross-section of the distal half 20 of the sheath 12. Inthe illustrated embodiment, the suction, endoscope, and irrigationchannels are arranged in a side-by-side fashion. The suction channel 14is shown larger than the endoscope and irrigation channels 16 and 18,respectively. As described above, the suction channel 14 is preferablysufficiently large to facilitate the removal of tissue and othersubstances around the operative site. The center channel 16 accommodatesthe endoscope (not shown). Preferably, the width of the endoscopechannel 16 is approximately 1 mm. The remaining lumen 18 provides a pathfor irrigation or insufflation of the operative site. This channel isalso preferably approximately 1 mm in size.

The overall diameter of the distal portion 20 of the sheath preferablyranges between 3 mm and 7 mm. It will be recognized that the width ofthe distal portion 20 of the sheath 12 is significantly smaller thanmany conventional optical surgical tools to provide increased patientcomfort, and adjustability and control of the surgical device during theoperative procedure. The selected size, however, will vary depending onthe number of channels necessary for the particular surgical procedure.

In yet another aspect of the illustrated embodiments of the presentinvention, the shape of the distal tip 28 of the sheath 12 may varydepending upon the particular application of the optical surgical device10. The particular tip structure may be selected to allow the physicianto directly view and precisely locate the desired operative site, andthen scrape and/or suction the target tissue or fluid. Examples ofcurved and blunt distal tips are shown in FIGS. 1, 7 and 8. A curved tip46 (FIGS. 1 and 7), for example, provides both physical and visualaccess to nearly any area of an operative site as the sheath 12 isrotated or manipulated manually by the physician. The curved tip 46 maybe useful in procedures such as aspiration biopsies. The hook-likeconfiguration facilitates the dislodging of the desired tissue from theoperative site (e.g., the endometrial lining of the uterine wall), anddirects the dislodged tissue into the suction channel 14. Preferably,the curved tip 46 is positioned sufficiently beyond the distal openingof the endoscope channel 16 to avoid obstruction of the endoscope.

In another preferred embodiment of the invention, the sheath 12 may beprovided with a blunt tip 44 (FIG. 8) which may be useful inintrauterine procedures. The blunt tip 44 allows the physician toclearly view the desired tissue, place the tip adjacent the tissue, andremove the tissue by scraping or suction. A sheath having a blunt tip 44may also be used in tubal insemination procedures in which the distaltip of the optical surgical device is inserted into a patient'sfallopian tubes. The blunt configuration of the tip provides anunobstructed view into the openings of the fallopian tubes. Inoperation, the physician simply places the blunt tip near the openingsof the fallopian tubes so that the semen held in one of the channels inthe sheath can be accurately injected into the tubal openings.

As illustrated in FIGS. 1, 7 and 8, the endoscope channel 16 is disposedbetween the suction and irrigation channels 14 and 18, respectively.Such a configuration provides for continuous cleansing of the tip of theendoscope during the surgical procedure. The continuous flow ofirrigating fluid provides an unobstructed view of the operative sitethrough the endoscope. In addition, the irrigating fluid may be suppliedor delivered only on demand. For example, if a continuous flow ofirrigating fluid is unnecessary, if the view through the endoscopebecomes clouded by blood or other tissue, the tip can instantly becleaned by applying suction and irrigation simultaneously. Thus, as theirrigating fluid flows into the operative site, across the tip of theendoscope, the fluid and any tissue may be quickly flushed out andextracted through the suction channel 14.

In another preferred embodiment of the present invention, the opticalsurgical device may be used for examining a patient's urethra andbladder. An embodiment of an optical urethroscope 50 is illustrated inFIG. 9. When used to examine female patients, the distal end 52 of theurethroscope 50 is inserted into the patient's urethra, similar to theoperation of the optical surgical device 10. Thus, preferably, thedistal end 52 of the urethroscope 50 is slimmer, i.e., has a smallerdiameter, than the proximal end 54.

The urethroscope 50 may be provided with multiple channels, or lumens56, 58 and 60 formed within an outer sheath 62. Preferably, an endoscope(not shown) is inserted into the center channel 58 of the sheath 62. Adrainage channel 56 is designated for outflow of fluids from theurethra, while an irrigation channel 60 is provided for inflow ofirrigating fluid.

The urethroscope 50 may also include an eyepiece coupled to an eyepieceport 64 at the proximal end 54 of the sheath 62, as shown in FIG. 9. Agasket may be inserted between the eyepiece port 64, at proximal end ofthe endoscope channel 58 of the sheath 62, and the eyepiece to preventleakage of urine or other fluid around the eyepiece during use. FIG. 9shows the eyepiece port 64 extending generally in-line with theelongated body of the sheath 62. As described earlier, such aconfiguration provides direct viewing capability of the operative sitewithout requiring the physician or video apparatus to be shifted ormoved whenever the sheath and eyepiece arrangement are rotated oradjusted.

Like the embodiment of the optical surgical device 10 illustrated inFIG. 1, the drainage channel 56 and irrigation channel 60 form thedrainage/irrigation port 66 which is offset from the proximal endoscopeport 54. The size and structure of the drainage and irrigation channels56 and 60 may be substantially configured to fit standard drainage andirrigation connectors and tubing.

In another aspect of the urethroscope embodiment of the presentinvention, the urethroscope may be equipped with an inflation medium,such as a balloon, to dilate the urethra, if necessary. Rather thanusing the conventional method of inserting graduated sizes of metal rodsto dilate the urethra, the urethroscope may be used for both examinationas well as dilation. As shown in FIGS. 9-11, a balloon 68 may beprovided around part of the distal end 52 of the sheath 62. The balloonpreferably is formed of a plastic or rubber material wrapped around theouter circumference of the distal section 52 of the sheath to beinserted into the patient.

The balloon 68 is coupled to a balloon inflation channel 71. The ballooninflation channel 71 extends longitudinally adjacent the irrigationchannel 60, as indicated in FIG. 11. An external source of an inflatingmedium (not shown) may be coupled to the balloon inflation channel 71 atthe balloon inflation port 70 shown in FIG. 9. In the illustratedembodiment, the balloon inflation port 70 is angled away from theballoon inflation channel 71, and therefore the body of the sheath 62,to facilitate easy hook-up to the inflation medium and minimizeobstruction of the viewing area. Preferably, the balloon inflation port70 comprises a luer lock system in which water, air or other inflatinggas that has been injected into the balloon through the ballooninflation port 70 cannot escape. The luer lock essentially acts as aone-way gas inlet.

Accordingly, during an examination procedure of the urethra, forexample, after the physician has inserted the urethroscope 50 into thepatient's urethra, the physician may quickly, yet controllably dilatethe urethra by inflating the balloon 68. As the balloon expands, theurethra is slowly forced to expand, or dilate. FIG. 10 illustrates across-section of the inflated balloon 68 surrounding the sheath 62.Preferably, the balloon 68 extends from outside of the patient to beyondthe length of the urethra so that the entire length of the patient'surethra may be dilated with minimal trauma and discomfort.

The size and construction of the described embodiment of theurethroscope may be varied to accommodate different patients andprocedures while minimizing discomfort. For example, the distal half 52of the sheath 50 (which will be inserted into a patient) preferably iscurved, as shown in FIG. 9. The slight curvature provides sufficientflexibility and access both physically and visually to the various areasof the operative site being examined. In addition, the distal tip 73 ofthe illustrated embodiment of the urethroscope may be rounded (FIG. 12)to facilitate more comfortable insertion. Preferably, the endoscope isinserted into the central channel 58 of the sheath 62 such that theendoscope viewing area protrudes from the rounded tip 73 of the sheath.As a result, the endoscope field of view is increased.

As illustrated in FIGS. 9 and 12, the drainage opening 72 at the distalend of the drainage channel 56 may be skewed off to the side of the tip73 of the sheath 62. Since drainage is a passive function, in contrastto active suction, the physician typically does not need to directlyviewed the drainage of fluid through the drainage opening 72 during theexamination procedure. Thus, the drainage opening 72 is preferablylocated to the side of the sheath tip to minimize interference with theoptical examination, as shown in FIGS. 9 and 12. In an alternateembodiment, drainage channel 56 may be eliminated.

Like the optical surgical device, the urethroscope sheath 62 ispreferably made of a semi-flexible material to provide for comfortableinsertion and manipulation with the patient. However, as discussedabove, the sheath material must be sufficiently rigid at the proximalend of the sheath to enable the physician to properly maneuver thedistal end of the sheath into the desired location. Accordingly, thediameter of the sheath 62 is larger toward the proximal end 54 forincreased strength and manipulability. The sheath is tapered toward itsdistal end 52 to minimize patient discomfort.

With regard to the described embodiments of the optical surgical deviceand the urethroscope device, the sheath 12 and 62 is disposable.Preferably, each sheath will be designated for single patient use only.After each examination or surgical procedure in which the sheath hasbeen inserted into the patient, the suction (or drainage)/irrigationport may be simply disconnected from the suction and irrigation sources,and the eyepiece and endoscope may be easily removed from (e.g., slippedout of) the respective endoscope channel. Consequently, the remainingempty sheath can be immediately disposed of without further cleaning orsterilization. Only the endoscope and the eyepiece may require cleaningand sterilization for future use. Thus, because of the disposablefeature of the outer sheath, the time and energy which would otherwisebe required to properly clean and sterilize the sheath are significantlyreduced.

In addition, because the sheath is presterilized before each single use,the physician simply needs to remove the already-sterilized sheath fromits packaging, attach it to the necessary suction/drainage andirrigation sources, insert the endoscope and attach the eyepiece. Thesurgical device is then ready for immediate use. Such constructionsignificantly decreases the complexity and margin for error duringexaminations and other operative procedures.

In the illustrated embodiments, the eyepiece coupled to the proximal endof the sheath and endoscope channel is arranged in-line with the sheathfor direct viewing capability. However, it will be recognized thatdepending upon the particular application or position of the patientduring the operative procedure, the eyepiece may be angled away from thebody of the sheath. Similarly, the suction (or drainage)/irrigation portmay be configured in a variety of other ways not shown in theillustrated embodiments to accommodate different configurations andpositions as necessitated by the examination procedure.

In addition, further embodiments may employ different numbers ofchannels as necessary for attachment to a variety of devices and/orsources necessary for different operative procedures. For example, achannel may be designated for the introduction of other instruments,such as a biopsy instrument for use in the patient's urinary bladder.Also, it will be recognized that other optical devices may be used toobserve the operative procedure.

The presently disclosed embodiments are to be considered in all respectsas illustrative and not restrictive. The scope of the invention beingindicated by the appended claims, rather than the foregoing description,and all changes which come within the meaning and range of equivalencyare, therefore, intended to be embraced therein.

We claim:
 1. An optical surgical apparatus operable with an opticalviewing device for examination of the genitourinary tract of a patient,the apparatus comprising:a disposable tube-shaped member having:an openproximal end and an open distal end, the tube-shaped member beingsemi-flexible and dimensioned for comfortable insertion into thegenitourinary tract of a patient, the overall diameter of the distal endbeing in the range of about 3 mm to about 7 mm, and the distal half ofthe tube-shaped member being slightly curved for ease of insertion andviewing access within a patient; at least two channels integrally formedwithin the tube-shaped member and extending between the open proximalend and the open distal end, including an endoscope channel forremovably receiving the optical viewing device, and an irrigationchannel for directing fluid to the operative site and to clean thedistal end of the optical viewing device; and a port at the openproximal end of the tube-shaped member communicating with the endoscopechannel, for removably receiving the optical viewing device; wherein thedistal end of the tube-shaped member defines a scraping tool for softtissue, and the endoscope channel is positioned at the distal end of themember for causing the optical viewing device, when received in theendoscope channel, to provide a view of a soft-tissue surface beingscraped by the scraping tool.
 2. The optical surgical apparatus of claim1, wherein the the port at the proximal end of the endoscope channel isco-axial with the tube-shaped member.
 3. The optical surgical apparatusof claim 1, wherein the diameter of the distal end of the channel whichreceives the optical viewing device is approximately 1 mm.
 4. Theoptical surgical apparatus of claim 1, wherein the tube-shaped membertapers from the proximal end to the distal end.
 5. An optical surgicalsystem for examination of the genitourinary tract of a patient,comprising:a disposable tube-shaped member having a plurality ofintegral channels extending therethrough, the tube-shaped member havingan open proximal end and an open distal end, the tube-shaped memberbeing semi-flexible and dimensioned for comfortable insertion into thegenitourinary tract of a patient, the overall diameter of the distal endbeing in the range of about 3 mm to about 7 mm, and the distal half ofthe tube-shaped member being slightly curved for ease of insertion andviewing access within a patient; an optical viewing device removablyreceived by one of the channels in the tube-shaped member at the openproximal end of the tube-shaped member and having a field of view at thedistal end of the tube-shaped member; an irrigation supply in flowcommunication with another one of the channels in the tube-shapedmember, such channel being positioned for directing irrigation fluid tothe operative site and to clean the distal end of the optical viewingdevice; and scraping means for scraping soft tissue in the field of viewof the optical viewing device; and means for removing scraped tissue andfluid from the patient, the means for removing tissue and fluid beingcoupled to another channel in the tube-shaped member defining a drainagechannel, wherein the tissue and fluid enter the drainage channel at theopen distal end of the tube-shaped member and exit the drainage channelat the open proximal end of the tube-shaped member.
 6. The opticalsurgical system of claim 5, wherein the the proximal end of the channelreceiving the optical viewing device is co-axial with the tube-shapedmember.
 7. The optical surgical system of claim 5, wherein the diameterof the distal end of the channel which receives the optical viewingdevice is approximately 1 mm.
 8. The optical surgical system of claim 5,wherein the drainage channel has the largest diameter of the pluralityof channels in the tube-shaped member.
 9. An optical surgical system forexamination of tissue and fluid in the genitourinary tract of a patient,comprising:a disposable sheath having a plurality of integral channelsextending therethrough, the plurality of integral channels defining atleast first, second and third channels, the sheath having a proximal endand a distal end, the distal end of the sheath for inserting into thepatient, the sheath being semi-flexible and dimensioned for comfortableinsertion into the genitourinary tract of a patient, the overalldiameter of the distal end of the sheath being in the range of about 3mm to about 7 mm, and the distal half of the sheath being slightlycurved for ease of insertion and viewing access within a patient; anoptical viewing device removably received by the first channel in thesheath at the proximal end of the sheath, wherein the optical viewingdevice extends from the proximal end to the distal end of the sheath andhas a field of view at the distal end of the sheath; an irrigatingsource in flow communication with the second channel in the sheath, theirrigating source including an irrigating solution to irrigate thepatient and clean the distal end of the optical viewing device; and thedistal end of the sheath having a scraping tool for removing tissue fromthe patient in the field of view of the optical viewing device, thescraping tool being proximate to the third channel in the sheath,wherein scraped tissue and fluid enter the third channel at the distalend of the sheath and exit the third channel at the proximal end of thesheath.
 10. The optical surgical system of claim 9, wherein the firstchannel containing the optical viewing device is disposed between thesecond and third channels.
 11. The optical surgical system of claim 9,wherein the optical viewing device comprises a bundle of optic fibers.12. The optical surgical system of claim 9, further comprising aneyepiece coupled to the optical viewing device at the proximal end ofthe sheath, wherein the eyepiece extends along the same line as thesheath.
 13. The optical surgical system of claim 12, further comprisinga gasket coupled to the eyepiece for preventing leakage of tissue,fluid, and irrigating solution into the eyepiece.
 14. The opticalsurgical system of claim 12, wherein the eyepiece includes a lockingmember for attaching to the optical viewing device.
 15. The opticalsurgical system of claim 12, wherein the eyepiece includes a focusingmechanism for magnifying and focusing an image viewed through theoptical viewing device.
 16. The optical surgical system of claim 12,further comprising a removal/irrigation port for coupling to externalsources of removal and irrigation, the removal/irrigation port beingdisposed at an angle from the eyepiece coupled to the optical viewingdevice at the proximal end of the sheath.
 17. The optical surgicalsystem of claim 16, further comprising a brace for supporting the anglebetween the removal/irrigation port and the eyepiece.
 18. An endoscopeassembly for optical examination of tissue and fluid around an operativesite within the genitourinary tract of a patient, comprising:adisposable sheath having a plurality of integral channels extendingtherethrough, and having a proximal end and a distal end, the distal endof the sheath having a tip for inserting into the operative site anddefining a scraping tool for scraping soft tissue at the operative site,the sheath being semi-flexible and dimensioned for comfortable insertioninto the genitourinary tract of a patient, the overall diameter of thedistal end of the sheath being in the range of about 3 mm to about 7 mm,and the distal half of the sheath being slightly curved for ease ofinsertion and viewing access within a patient; a fiber-optic viewingdevice removably received by one of the channels in the sheath defininga viewing channel, wherein the fiber-optic viewing device extends fromthe proximal end of the sheath to the tip of the distal end of thesheath and has a field of view at the distal end of the sheath, whichfield of view overlaps the operative site when the scraping tool isscraping tissue at the operative site; irrigation means for irrigatingthe operative site with an irrigating solution, the irrigation meanscoupled to another one of the channels in the sheath defining anirrigation channel, wherein the irrigating solution simultaneouslycleans the fiber-optic viewing device; and drainage means for removingtissue and fluid from the operative site, the drainage means coupled toanother one of the channels in the sheath defining a drainage channel,wherein the tissue and fluid from the operative site enter the drainagechannel at the distal end of the sheath and exit the drainage channel atthe proximal end of the sheath.
 19. The endoscope assembly of claim 18,wherein the viewing channel is disposed between the irrigation anddrainage channels.
 20. The endoscope assembly of claim 18, wherein thedrainage channel has the largest diameter of the plurality of channelsin the sheath.
 21. The endoscope assembly of claim 18, furthercomprising:an eyepiece coupled to the fiber-optic viewing device at theproximal end of the sheath, wherein the eyepiece extends along the sameline as the sheath, and a drainage/irrigation port for coupling toexternal sources of removal and irrigation, wherein the irrigationchannel and the drainage channel are separated from the viewing channelsuch that the drainage/irrigation port is skewed at an angle away fromthe eyepiece at the proximal end of the sheath to facilitate easiermanipulation and rotation of the sheath during the examination.
 22. Theendoscope assembly of claim 21, wherein the eyepiece further includes:alocking member for attaching the eyepiece to the fiber-optic viewingdevice, and a focusing mechanism for magnifying and focusing an imageviewed through the fiber-optic viewing device.
 23. A method of making anoptical surgical apparatus for optically examining tissue and fluidaround an operative site within the genitourinary tract of a patient,comprising the steps of:providing a disposable sheath having a pluralityof channels extending therethrough, an open proximal end and an opendistal end defining a scraping tool, the distal end of the sheath forinserting to the operative site, wherein a first one of the channelsdefines a viewing channel, a second one of the channels defines anirrigation channel, and a third one of the channels defines a drainagechannel, the sheath being semi-flexible and dimensioned for comfortableinsertion into the genitourinary tract of a patient, the overalldiameter of the distal end of the sheath being in the range of about 3mm to about 7 mm, and the distal half of the sheath being slightlycurved for ease of insertion and viewing access within a patient;inserting an endoscope into the viewing channel in the sheath, theendoscope extending from the proximal end of the sheath to the distalend of the sheath, the proximal end of the sheath and endoscope defininga viewing port, the endoscope having, at the distal end of the sheath, afield of view in the vicinity of the scraping tool; attaching aneyepiece to the viewing port; and separating a drainage/irrigation portfrom the eyepiece, the drainage/irrigation port for coupling to externalsources of drainage and irrigation.
 24. A method of using an opticalsurgical apparatus for optically examining tissue and fluid at anoperative site within the genitourinary tract of a patient, comprisingthe steps of:inserting an endoscope into one of a plurality of channelsextending through a disposable sheath, the sheath having a proximal endand a distal end, the distal end defining a scraping tool for scrapingtissue at the operative site the endoscope extending from the proximalend of the sheath to the distal end of the sheath, the proximal end ofthe sheath and endoscope defining a viewing port, further wherein theplurality of channels define an irrigation channel and a drainagechannel, the sheath being semi-flexible and dimensioned for comfortableinsertion into the genitourinary tract of a patient, the overalldiameter of the distal end of the sheath being in the range of about 3mm to about 7 mm, and the distal half of the sheath being slightlycurved for ease of insertion and viewing access within a patient;coupling sources of drainage and irrigation to the drainage andirrigation channels; inserting the distal end of the sheath to theoperative site; scraping soft tissue at the operative site with thescraping tool while viewing the operative site through an eyepiececoupled to the viewing port; and discarding the sheath following theabove steps.
 25. The method of claim 24, further comprising the step ofirrigating the operative site with an irrigating solution through theirrigation channel.
 26. The method of claim 24, further comprising thestep of removing tissue, fluid and irrigating solution from theoperative site through the drainage channel.